Global CMC Regulatory Strategy Director

Posted 2 days ago

zailabSouth San Francisco (CA)

Regulatory Affairs Managers Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Manager

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About the role

Zai Lab Limited seeks a senior CMC regulatory leader to drive global regulatory strategy for both small molecules and biologics from its South San Francisco office. You will oversee IND/CTA and NDA/BLA submissions, coordinate with health authorities, and guide cross-functional teams across development stages. The role requires strong leadership, deep CMC knowledge, and fluency in English and Chinese, with a track record of successful global submissions and regulatory interactions.

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